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Quality Coordinator
3 months ago
Job Title: Quality Control Coordinator
Location: Boca Raton, FL USA 33166
Pay rate: $18.70/hr on w2
Duration: 12 Months (Possible extension)
Summary:
The QC Coordinator is responsible for receiving samples, determining test requirements, filling out Product Evaluation forms for testing, submitting samples to the lab, sending out samples for 3rd party testing, providing test reports for sister site testing, releasing materials using inventory management software and preparing CofAs. Update department heads and MRB on pending laboratory investigations. Support supervisors in gathering and organizing testing information and trending data. Perform any duty as requested by management.
- Responsibilities:Responsible for providing status updates to other departments regarding the submission of samples (release testing, R&D, sister site, consumer complaints, extended expiration date and stability (sample handling and control, data entry, etc.).
- Responsible for assigning testing requirements to each incoming raw material or bulk lot and providing test requirements to Supervisors for assignment to Analysts on a daily basis.
- Communicates with appropriate personnel concerning re-sampling and to acquire missing information such as documentation and specification issues.
- Associate may support various processes in the Change Control Record Program.
- Responsible for creating reports including but not limited to quality data trending, informational spreadsheets, laboratory log spreadsheets, stability spreadsheets, etc.
- Reviews certificates of analysis (COA) from raw material suppliers, QA/QC reports and other quality documents.
- Generates CofAs for bulks based on the completed test reports.
- Provides information related to the testing of Customer Complaints as part of the investigation process.
- Assist Quality Management with the coordination and submission of outside lab samples and the reporting of results.
- Creates Purchase Orders for the laboratory supplies.
- Provides training and technical support to the Quality Coordinator group regarding raw material and bulk testing requirements.
- Routinely use AS400, SAP, LIMS, PLM, and Veeva database platforms for managing information.
- Experience:1 to 3 Years of experience in chemical, micro-biology, or related field optional
- Associates / Bachelors degree, Biology or related sciences (preferred)
- Problem solving skills used in performing the job duties Mathematics used in the job (from basic counting to basic statistical analysis)
- Education, Certification, Licenses & Registrations:Computer literate, Math, Basic statistics, Office, technical, or trade skills required
- Equipment skills required to perform the job duties Lift up to 30 pounds
- Able to read and understand Chemistry, micro-biology terminology and documentation Knowledgeable
- GMP regulations for solid dose, tablet capsule testing for release
- Familiar with FDA and USP testing methodologies
Required: Good English verbal and written skills. Basic mathematic skills.
- Expected high performance behaviors:Exhibit positive attitude regarding work and responsibilities
- Ability to work collaboratively within teams
- Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
- Continuously looks for ways to do things faster and better, while maintaining high quality standards
- Is creative and intellectually curious; tries different and Client ways to solve obstacles
Physical Demands:
Ability to lift approximately 40 pounds.
Work environment may be exposed to powders, chemicals and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish)